Median Technologies (ALMDT) announced that the Company has officially commenced operations with all investigator sites participating in the pivotal validation plan for its iBiopsy® Lung Cancer Screening (LCS) AI/ML tech-based CADe/CADx Software as Medical Device (SaMD). For the purposes of its pivotal validation plan, Median Technologies has signed clinical research agreements with world-class academic healthcare institutions, which are leading healthcare centers for the management of lung cancer patients. Median's pivotal validation plan is composed of a pivotal standalone performance study (MT-LCS-002) and an international Multi-Reader Multi-Case (MRMC) pivotal clinical trial (MT-LCS-004).

Both pivotal standalone study (MT-LCS-001) and pivotal clinical trial (MT-CS-004) results will be respectively submitted to the FDA for obtaining the 510(k) clearance and to a European notified body for obtaining CE Marking. The pivotal validation plan will mainly rely on the contributions from the sites listed below (by institution size): US-based sites: The University of Texas MD Anderson Cancer Center, Houston, TX, USA, Hospital of the University of Pennsylvania (Penn Medicine), Philadelphia, PA, USA, Baptist Memorial Health Care and Baptist Clinical Research Institute, based in Memphis, TN, USA. Europe-based sites: Clinica Universidad de Navarra, Departments of Respiratory Medicine and Radiology, Pamplona and Madrid, Spain, Instituto de Investigacion Sanitaria de la Fundacion Jimenez Diaz (IIS-FJD), Madrid, Spain.

The international MRMC pivotal clinical trial Lead Principal Investigator will be Anil Vachani, MD, the director of Clinical Research for the Section of Interventional Pulmonary and Thoracic Oncology at Penn Medicine, and an associate professor of Pulmonary Medicine in the Perelman School of Medicine at University of Pennsylvania.